Diagnosis: Cardiac/Circulatory Problems.
Treatment: Pharmacy/Prescription Drugs.
The insurer denied Vascepa 1GM OR CAPS.
The denial is upheld.

This case involves a male patient with a history of type 2 diabetes, hypertriglyceridemia, and hypertension (HTN), who has been treated with maximally tolerated statin therapy and has been prescribed Vascepa 1 gram (gm) capsule for additional lowering of triglycerides. The patient's health plan has denied coverage for the non-formulary medication, Vascepa 1gm capsule, because clinical documentation has not demonstrated treatment failure and intolerance to the generic version icosapent ethyl nor documented treatment failure to the preferred list of medications for the treatment of hyperlipidemia. The patient's treating provider is appealing this denial.
At issue is whether the formulary drugs will be or have been ineffective, would not be as effective as the non-formulary drug or would have adverse effects.

The health plan's determination is upheld in whole.

The REDUCE-IT trial published in The New England Journal of Medicine (NEJM) in 2019 was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled patients with established cardiovascular disease or with diabetes and other risk factors treated with maximally tolerated statin therapy and who had a fasting triglyceride level of 135 to 499 milligrams (mg)/deciliter (dL). (1) Patients randomized to receive 2 gm of icosapent ethyl twice daily (total daily dose, 4 gm) experienced a significantly lower risk of cardiovascular events including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina compared to placebo. Based on these results, Vascepa (icosapent ethyl) was granted United States Food and Drug Administration (FDA) approval as an adjunct to maximally tolerated statin therapy to reduce the risk of cardiovascular (CV) events in adult patients with elevated triglyceride levels greater than or equal to (>=)150 mg/dL and established cardiovascular disease or diabetes mellitus along with 2 or more additional risk factors. According to the patient's records provided for review, there has been no case documentation indicating treatment failure, intolerance, or adverse effects to Vascepa 0.5gm. Vascepa 0.5gm, as a listed formulary medication, would be medically appropriate to treat this patient's hypertriglyceridemia and reduce his risk of future cardiovascular events.
Therefore, the formulary drugs have not been ineffective, and would be as effective as the non-formulary drug.